Medical laboratory services are essential to patient care and therefore have to be available to meet the needs of all patients and the clinical personnel responsible for the care of those patients.

The conduct of a clinical investigation - i.e any systematic investigation in or on one or more human subjects, undertaken to assess the safety and/or performance of a medical device - is one of the most time-consuming and resource-intensive activities that a medical device manufacturer can face.

Clinical investigations are a key feature of the Medical Devices Directive. They are even more important under the Medical Devices Regulation. To read about European Medical Devices Regulations for medical device clinical investigations, download our whitepaper.

For these reasons, medical device manufacturers should ensure that the purpose of the clinical investigation is clear; all applicable regulations, common specifications (e.g. concerning device-specific requirements relevant for clinical investigations), international standards, European guidance documents, and national guidance documents have been identified; all persons involved with the study understand their roles and responsibilities, and the study is well organized and conducted in accordance with relevant quality management systems (QMS) practices. 

Clinical investigations standards, in particular BS EN ISO 14155:2020, can help manufacturers of medical devices ensure they are complying with regulations when conducting clinical investigations.

How can Clinical Investigations Standard BS EN ISO 14155 Help your Business?

This international clinical investigations standard sets out good clinical practice for conducting medical device clinical investigations using people. BS EN ISO 14155:2020 wants to protect people’s rights, safety, and well-being, and ensure the credibility of results. 

This standard deals with good clinical practice for the design, conduct, recording, and reporting of clinical investigations carried out on human subjects to assess the safety or performance of medical devices for regulatory purposes. It provides a way to verify the quality and fitness for purpose of clinical data obtained for regulatory purposes. 

The principles set out in BS EN ISO 14155:2020 also apply to all other clinical investigations and should be followed as far as possible, considering the nature of the clinical investigation and the requirements of national regulations.

The clinical investigations standard specifies general requirements intended to: 

• Protect the rights, safety, and well-being of human subjects

• Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results

• Define the responsibilities of the sponsor and principal investigator

• Assist sponsors, investigators, ethics committees, regulatory authorities, and other bodies involved in the conformity assessment of medical devices

• It also contributes to UN Sustainable Development Goal 3 on ensuring healthy lives and promoting well-being for all at all ages. This goal will be supported by the provision of quality healthcare, effective medical equipment, and safe clinical practice which is what this standard helps promote.

There have been a number of developments since the 2011 publication of the second edition that necessitated an update. Drivers included the more stringent requirements for clinical data in the European Medical Devices Regulation. Also, there was a need to ensure greater consistency with new guidelines on good clinical practice for pharmaceuticals. BS EN ISO 14155:2020, therefore, includes additional guidance on:

• Risk management in the design and conduct of clinical trials

• Informed consent

• Protection of vulnerable populations

• Arrangements for publication, transparency, and data protection

This third edition includes clarifications and expansions that will ensure greater compliance with regulatory requirements. These will better meet user needs, improve patient safety, speed up the route to market and provide greater confidence in the regulatory compliance of marketed products.

Other Key Medical Device Standards

There are several other key standards that your organization can adopt to ensure they are working to best practices when conducting their clinical investigations:

BS EN ISO 13485:2016+A11:2021 is the internationally recognized quality management system (QMS) standard for the medical device industry. It specifies requirements for a QMS for organizations involved in one or more stages of the lifecycle of a medical device. It provides the basis for ensuring consistent design, development, production, installation, and delivery of products that are safe for their intended purpose.

BS EN ISO 15189:2022 Medical laboratories - Requirements for quality and competence specify the needs for quality and competence within medical laboratories. This International Standard can be applied by medical laboratories to develop their quality management systems whilst assessing their own competence. It can also be used for recognizing the proficiency of medical laboratories by customers, regulating authorities, and accreditation bodies.

BS ISO 17593 is an international standard for manufacturers of in-vitro medical devices, and other organizations, such as regulatory authorities and conformity assessment bodies, who have responsibility for assessing the performance of those systems. It specifies requirements for in vitro measuring systems for self-monitoring of vitamin-K antagonist therapy, including performance, quality assurance, and user training and procedures for the verification and validation of performance by the intended users under actual and simulated conditions of use.

BS ISO 14971 international standard helps medical device manufacturers establish, document, and maintain a systematic risk management process across all phases of the lifecycle of a medical device. The use of the standard helps streamline the regulatory processes that enable entry to selected markets.

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